OBJECTIVES/GOALS: The goal of this study is to develop a multi-centered Translational Studio model that can help in the development of quality translational studies using resources from four different institutional partners (University of Texas Medical Branch, Texas Southern University, University of Houston Clear Lake and Houston Methodist). METHODS/STUDY POPULATION: We conducted two rounds of four Futures Workshops for a total participation of 28 stakeholders from four different partners. Future Workshops were used to critique, envision, and articulate novel “futures” that can be achieved at least partly through design practices (Muller, 2002). In the first round of workshops, we asked participants about their institutions’ strengths, weaknesses, resources and investigator needs regarding the Studio. In the second round we asked about different studio models, pros and cons of each model and guiding principles for a studio. Alongside a pragmatic content analysis, multi-stage deductive and inductive qualitative analyses were used to understand people’s views on the future of a multi-institutional Clinical Trials Studio. RESULTS/ANTICIPATED RESULTS: The first-round workshops’ analysis described peoples’ goals for what the studio should be. The future desired studio was described as guide, matchmaker, initiator and advocate. The second-round workshops’ analysis discussed the pros and cons of a variety of possible models including, centralized, decentralized, and topic-specific (and allowed other suggestions) while also describing principles for the guidance of a studio. Here the analysis showed people wanted certain characteristics for the studio (i.e. effective, efficient, locally-responsive, consistent, etc.). They also prescribed four principles that a studio should be guided by: non-hierarchical partnership, user-centeredness, respect/collegiality, and sharing. DISCUSSION/SIGNIFICANCE: The future workshops were useful in developing a shared multi-institutional Clinical Trials Studio model that is planned to be deployed in 2025. Participants valued a studio that was both directly supportive to participants and played a role in creating or advocating for institutional resources and policy for research.

OBJECTIVES/GOALS: The Clinical Research Professionals (CRP) group was founded in 2000 by research managers at Cincinnati Children’s Hospital Medical Center (CCHMC) as an avenue to share research processes, ideas, successes, and community. The group has developed and evolved at CCHMC to meet the needs of CRP members. METHODS/STUDY POPULATION: CRP has evolved to meet the needs of the clinical research community at CCHMC. In 2008, monthly education meetings and a Research Educator supported a standardized onboarding process. CRP hosted the inaugural CRP Appreciation Day in 2010 to recognize researchers. The group established the CRP Leadership Committee (CRPLC) in 2011 and by 2016 expanded to include subcommittees. Career development opportunities include onsite clinical research certification exams and a centralized process for advancement. CRP updated processes and onboarding materials to electronic formats during the pandemic and now includes nursing, data management, and University of Cincinnati representation on the CRPLC. RESULTS/ANTICIPATED RESULTS: The culmination of 20+ years of CRP has led to the current state of CRP at CCHMC. CRP operates an internal website to collate all activities and resources, including educational opportunities and helpful links related to CCHMC research processes. CRP currently has leadership, membership, education, and regulatory committees providing opportunities for all clinical research professionals to join, collaborate, and grow within CCHMC and beyond. Established career pathways and centralized CRP advancement guidelines support career development. The centralized REDCap onboarding tool is accessible at any time for initial onboarding and then continuing education. DISCUSSION/SIGNIFICANCE: The formation and evolution of CRP, developed by work of past CRPs, has fostered an innovative community to meet clinical research needs through education, career development, and process standardization. We aim to continue to disseminate knowledge and lessons learned beyond our institutional walls.

OBJECTIVES/GOALS: A diverse workforce is an aspiration of CTSIs and embedded in goals to build D&I workforce capacity. However, little research describes the diversity of the current workforce. We assessed current assets, opportunities, and diversity of D&I efforts at Frontiers and characterized investigators and those supported by services offered. METHODS/STUDY POPULATION: In January 2021, Frontiers convened a working group to identify existing D&I assets and needs in the CTSI multi-state catchment area. The committee catalogued existing training and consultation resources and services, which the CTSI supported with infrastructure to support, track, and evaluate ongoing efforts. We obtained data from the evaluation platform and conducted descriptive analyses of the investigators and service uptake among two programs offered, contrasting the workforce with national data obtained from the American Academy of Medical Colleges (2022) and the National Institutes of Health (2018). RESULTS/ANTICIPATED RESULTS: Ninety individuals at 9 institutions across Kansas and Missouri identified as implementation researchers. Since 2022, 28 D&I consultations were provided, 92% for grant applications. Five early-stage investigators were identified for career development in an NIH-supported Health Equity and Implementation Center (ESI). The network mirrors the larger workforce regarding underrepresented racial/ethnic minorities (18%) and new investigators (60%). More women (76%) are represented in the D&I network and among ESIs (80%) than the academic workforce (44%), but significantly fewer women used consultation services (p<0.001). Lower proportions of underrepresented minority investigators (p<0.001) and investigators from disadvantaged statuses (p=0.027) accessed consultations services. DISCUSSION/SIGNIFICANCE: Investigators underrepresented in science on multiple dimensions were less likely to use consulting services, Outreach for consultation services may be necessary, if needs are not being met in other programs. Further exploration of overall D&I workforce trends is needed to ensure goals for the field and the CTSA network are achieved.

OBJECTIVES/GOALS: Immediate negative impact of the COVID pandemic on CTSA T trainees and K scholars was reported in 2020 to be lack of access to research facilities, clinics, human subjects, and team members, and a need for homeschooling. In this study we examined in more detail the perceived impact of the COVID pandemic on training and career development three years later. METHODS/STUDY POPULATION: CTSA T trainees and K scholars were surveyed in May-June 2023 to assess the impact of the COVID-19 pandemic on training and career development. Data were included from 309 T trainees and K scholars appointed in 2018-2023 at 50 institutions, with good representation from states that were heavily impacted by COVID. Respondents included 76 past and 64 current T trainees, and 56 past and 113 current K scholars. There were no significant differences in race, ethnicity, or gender between T and K respondents. Significantly more K scholars reported both being married or in a committed relationship, and having children. Survey items included the same questions asked in the 2020 survey, plus additional new questions. Results compare impact for T trainees and K scholars. RESULTS/ANTICIPATED RESULTS: K scholars were more negatively impacted for access to clinic/human subjects, home environment, child care, access to staff, increased clinical responsibilities, and other hospital service. T trainees and K scholars reported higher positive impact than in 2020, for having more time to think/write and develop new research ideas. About 2/3 of respondents reported returning to research full-time by April 2021, and the remaining by August 2021. Lasting changes in career progression or research direction were reported as both positive and negative (48%), negative (25%), or positive (10%). Most (2/3) respondents in faculty positions reported that a time extension was available for promotion and/or tenure. Additional in-depth analysis will be presented, based on qualitative analysis of open-ended questions. DISCUSSION/SIGNIFICANCE: Despite research shutdowns in response to the COVID-19 pandemic that lasted for about a year, CTSA T trainees and K scholars were remarkably resilient. They were able to continue some research activities and professional development activities, and developed strategies to maintain productivity and minimize impact on their training duration.

OBJECTIVES/GOALS: Clinical and Translational Science Award (CTSA) hubs are launching D&I Science cores to provide resources and services to promote the translation of clinical evidence into practice. We developed a D&I Science Core strategic plan reflecting our research community’s needs by assessing Implementation Science (IS) competencies. METHODS/STUDY POPULATION: The Tufts CTSI D&I Science Core was launched in early 2023. To design services that meet research community needs, we conducted a survey and key informant interviews based on Padek etal.’s list of Implementation Science (IS) competencies. The competencies are organized into four domains (Definition, Background, and Rationale; Theory and Approaches; Design & Analysis; and Practice-Based Considerations) and categorized by expertise level (beginner, intermediate, advanced). Participants who had attended or expressed interest in a D&I interest group were asked via an email survey to rate their level of confidence in completing selected IS-related research activities, about their experience with IS research or practice, and the types of resources, services and training they desired. RESULTS/ANTICIPATED RESULTS: Twenty researchers (20/65, 31%) submitted survey responses and six researchers participated in in-depth interviews. Survey respondents felt most confident in engaging stakeholders in IS research and least confident selecting a model or framework for a study. Results suggest that researcher capacity building is needed to: • Understand IS models and frameworks and their approaches, strengths, and limitations • Select and use models and frameworks in studies • Assemble IS teams and prepare grant proposals Suggestions for resources, services, and training, include: • Customized education to address diverse needs, knowledge levels, and learning styles • Promotion of D&I Core consultations and grant support services • Sharing of successful proposals to help researchers learn how to apply IS methods DISCUSSION/SIGNIFICANCE: A strategic workplan for the D&I Science Core was developed and implemented to address the findings. Initial emphasis is on developing easily accessible resources and timely consultations for investigators new to IS needing to apply these methods in current grant proposals, while also providing training resources for deeper skill building.

OBJECTIVES/GOALS: This project aims to improve the design of medical technology for global health by addressing gaps in engineering education. Our primary goal is to develop open educational resource’curriculum boosters’ that can be added to existing BME curricula to build skills in transdisciplinary collaboration, practical ethics, and failure resilience. METHODS/STUDY POPULATION: A phasic mixed-method research strategy has been employed. The Needs Analysis includes a systematic review and meta-analysis of existing knowledge regarding the three conceptual pillars of Transdisciplinary Collaboration, Practical Ethics, and Integrated Resilience. The Behavioral Study includes surveys, interviews, observations, and biometric data collection from working engineers, engineering students, global health stakeholders, and clinicians. The Validation Study will be conducted via small group workshops, a semester-long engineering design course, and a summer study-abroad course. Data collected will be analyzed and used to refine the proposed educational strategies. RESULTS/ANTICIPATED RESULTS: The final educational strategies will be structured into 'curriculum boosters' and published as open educational resource materials. The boosters and their supporting data will be made available to other engineering education programs with the goal of promoting widespread adoption and integration of these methods. DISCUSSION/SIGNIFICANCE: The long-term outcome of this ongoing work is to train a new generation of engineers prepared to participate adeptly in the co-design of technological solutions for complex global healthcare challenges by working ‘with, not for,’ clinicians, communities, and other stakeholders in peripheral healthcare settings.

OBJECTIVES/GOALS: Scientists are increasingly confronted with 'science critical' #_msocom_1 belief systems. The politicization of science fuels hesitancy towards evidence-based therapies. To overcome these barriers, we aim to devise strategies to communicate clinical translational science (CTS) through art. METHODS/STUDY POPULATION: A two-year pilot artist-in-residency (AIR) program embedded in the Translational Research Immersion Program (TRIP). Since 2009, TRIP contributes to CTS Workforce Development (WD) through a 10-week mentored, curriculum-rich summer undergraduate research experience. Students are recruited from 5 regional institutions, 6 HBCUs, and the University of Puerto Rico. AIR is composed of 3 phases: the “Immersive Phase” where the artist gains intensive exposure to the scientific process through the lived experience of TRIP students, the “Productive Phase” where the artist conceptualizes the process of CTS into works of art, and the “Engagement Phase” where the CTS workforce, artists, and community members coalesce around science-to-art materializations. RESULTS/ANTICIPATED RESULTS: In 2022 & 2023 the AIR participated in ~35hrs of CTS research seminars, panel discussions, and professional skills workshops. Additional TRIP student-AIR interaction occurred in focus groups including visits to mentor’s labs. An AIR-led workshop culminated in an Empowering CTS Communication event where TRIP students engaged with community members through elevator pitches of their CTS summer project on a speed-rotating basis. A month-long art-CTS exhibition planned for 3/2024 will feature contributions from AIR, TRIP students, and ITMAT community members. Qualitative insights were that TRIP is an effective art-science incubator, students strengthened their CTS communication skills, art functions as an icebreaker between science and communities with an ocean of opportunities for science education. DISCUSSION/SIGNIFICANCE: AIR embedded into existing CTS WD programs is proposed as creative approach to strengthen the reputation of science in the public. CTS-informed art functions as connective tissue between public and CTS workforce. The hands-on experience to adopt art as a science communication tool is a powerful soft skill for the next generation of CTS investigators.

OBJECTIVES/GOALS: We will reduce the number of research staff by 50% within 6 months that are non-compliant with completing the Good Clinical Practice (GCP) course without increasing costs as measured by salary and benefits for staff involved in the tracking and assignment process. We will also introduce a GCP policy to define the education requirements for GCP training METHODS/STUDY POPULATION: We touted focus groups to stakeholders for input on workflows with graphs, surveys, and meetings in the onset and throughout the project. This input prompted us to develop a staff guide outlining the modification process of removing a staff name from an IRB trial if they are no longer active in the trial. A workflow and root cause analysis were done resulting in the implementation of one gatekeeper for assigning and tracking completions, instead of three staff. Successfully reconciling the non-compliant report, which extracted data from three databases, allowed us to eliminate 174 names from the report, which originally comprised 792 names. IRB modifications were entered into the IRB system for these 174 names. We also put into effect a GCP policy for the institution, where none had previously existed. RESULTS/ANTICIPATED RESULTS: * In 3.5 months, we decreased the GCP non-compliance rate by 50% from 792 to 399. * We removed 22% of names from the 792 from the report due to their status of being non-employees, or Emeritus, or not in research anymore. * We discovered a data type issue in the non-compliance report that shuffled the MAX calculation, therefore not requiring some staff to complete the training. * We developed a new process for assigning training, resulting in faster compliance rates for the institution. It included sending emails to users two months before their training expired before we assigned the course to them. * We reconciled the non-compliance report, and it decreased the effort with staff involved in GCP for grant renewals and audits in numerous other departments. * Developed an escalation procedure for non-compliant staff. DISCUSSION/SIGNIFICANCE: Failure to address our GCP non-compliance rates could have put our institution at risk for potential penalties. With 4400+ research personnel listed on active trials the interventions we implemented accelerated our compliance rate by assigning the refresher course monthly and this also resulted in no disruption to staff completing the training.

OBJECTIVES/GOALS: Quantitative Staff are an essential workforce for biomedical research. While faculty can engage with peers locally and through national organizations, similar opportunities are limited for staff and often do not meet their unique needs and interests. Creating a professional community is valuable for supporting and developing this workforce. METHODS/STUDY POPULATION: We established the Quantitative Scientific Staff National Network (QS2N2) with the mission to provide professional development and networking opportunities, and to serve as an information resource and advocate through the fostering of community among staff quantitative analysts at any career stage. The initial membership outreach was to all Biostatistics, Epidemiology, and Research Design (BERD) programs through members of ACTS BERD Special Interest Group (SIG). We created a Leadership Team and an Advisory Board consisting of staff and faculty biostatisticians with experience working as or managing staff to govern the network. A Core Planning Committee consisting of 15 members guides planning, implementation, and execution of network activities as operationalized through subcommittees. RESULTS/ANTICIPATED RESULTS: The network currently has 131 members from over 30 health science institutions. Subcommittees focused on Education and Training, Membership, Communication and Web Development, and Mentoring were created and are developing events, programs and infrastructure to further the network’s mission. Network events such as webinars will be offered quarterly; with our first event planned for Nov 3rd. Expansion and maturation of QS2N2 will be done through regular remote meetings where members can connect with peers at other institutions, engage in career development activities, and attend technical seminars. Additional membership outreach will seek to connect with staff in government and private sectors. DISCUSSION/SIGNIFICANCE: Knowledgeable, highly skilled collaborative analysts (e.g., biostatisticians, data scientists) are an essential workforce in clinical and translational science and health research centers.The QS2N2 will support professional development, engagement and growth of this critical workforce which is necessary to advance quality research.

OBJECTIVES/GOALS: To evaluate the feasibility, acceptability, and appropriateness of a 1:1 peer-delivered psychosocial support intervention to family caregivers of hospice patients with cancer, and determine a range of potential effects of the intervention on psychological distress symptoms and perceptions of the caregiving experience. METHODS/STUDY POPULATION: Quantitative and qualitative data were collected from hospice caregivers of cancer patients who participated in a non-controlled pilot feasibility trial of a 1:1, peer-delivered psychosocial intervention called Peer Caregiver Navigation (PCN). The purpose of this study was to evaluate the feasibility, acceptability, and appropriateness of delivering PCN to hospice family caregivers of cancer patients, and to determine a range of potential effects of PCN on caregivers’ anxiety symptoms, depressive symptoms, self-efficacy, and benefit finding. Qualitative data were analyzed using deductive thematic analysis. For our study outcomes, we used both parametric and nonparametric t-tests to examine mean differences between outcomes at baseline and midpoint, and baseline and endpoint. RESULTS/ANTICIPATED RESULTS: The findings demonstrate that Peer Caregiver Navigation (PCN) is acceptable, appropriate, and feasible to deliver to hospice family caregivers of cancer patients. Appropriateness of our selected target outcomes was determined by confirming expected measurement change in depressive symptoms (lower), anxiety symptoms (lower), benefit finding (higher), and self-efficacy (higher). Exit interviews revealed that participants responded favorably to our selected measures for these outcomes and to our data collection time intervals. Moreover, recruitment and consenting processes, survey completion rates, and attrition outcomes (i.e., study exit due to active withdrawal vs. patient death) were analyzed to inform recruitment and retention feasibility for future studies. DISCUSSION/SIGNIFICANCE: Peer Caregiver Navigation (PCN) was determined to be feasible, acceptable, and appropriate to hospice family caregivers of patients with cancer. Moreover, PCN has the potential to improve caregivers' symptoms of psychological distress by providing them much needed psychoeducation, coping skills training, and emotional support.

OBJECTIVES/GOALS: Tobacco use remains a significant public health problem in rural America. Community health centers (CHCs) can help reduce the burden of tobacco use in rural areas, but we know little about their knowledge and implementation of best practices for tobacco control. This study assessed the knowledge and existence of tobacco control practices in rural CHCs. METHODS/STUDY POPULATION: Using a cross-sectional study design, we electronically surveyed health administrators and providers (n=64) in six rural CHCs in Louisiana between March 2021 and June 2023. The assessment measured 1) knowledge of the U.S. Public Health Service Clinical Practice Guideline for Treating Tobacco Use, 2) the priority given to smoking cessation programming, 3) the presence of best practices for tobacco control programming, such as having a tobacco control champion and team, 4) establishment of treatment and smoke-free campus policies, and 5) existence of referral procedure to external cessation services. We used descriptive statistics to characterize survey participants and responses. RESULTS/ANTICIPATED RESULTS: Most of the respondents were female (80%), White (61.8%), between 35 and 49 years of age (48.1%), and non-smokers (72.7%). Only half (51.6%) reported knowledge of the guideline for treating tobacco use among all respondents. Only a third (32.8%) said their health center gave smoking cessation high priority relative to other health priorities. Only a third (35.9%) reported having a tobacco champion; less than a fifth (18.8%) said they had a tobacco control team at their health center. Although all health centers had a smoke-free campus policy, about a quarter (23.4%) were unaware of the policy. Less than a quarter (23.4%) reported having a written policy for smoking cessation treatment at their health center, and less than half (46.7%) knew about cessation services to which they could refer patients. DISCUSSION/SIGNIFICANCE: Rural CHCs had limited knowledge of the guideline for tobacco use treatment. Smoking cessation lacked priority, and the prevalence of tobacco control best practices implementation was low. Rural CHCs must improve their implementation of guideline-recommend policies and clinical strategies to promote treatment and reduce the burden of tobacco use.

OBJECTIVES/GOALS: We developed institution-wide RCR training to include all required elements; support trainees to identify key ethical questions that arise in research; and to identify methods to identify a solution; and disseminate results. METHODS/STUDY POPULATION: In 2011, we participated in developing an experimental model of RCR training led by the University of Michigan. We continue to offer this training model to career development awardees in clinical and translational research at OHSU across the institution. Interactive discussion in faculty and trainee groups includes responsibilities of a researcher and a systematic process to address real world research ethics issues. Each participant identifies a key research issue they have encountered and presents a poster at the final session. We have tracked post-training assessment of participant confidence in ethical decision making and in the range of topics identified by participants. RESULTS/ANTICIPATED RESULTS: Since 2012, 227 scholars and trainees have participated in the program with 44 faculty mentors facilitating. We will describe the current curriculum as it has evolved over the past 12 years, presenting trainees with an approach to identify ethical challenges that arise in their research and identify approaches to find a practical solution. We will report on the specific challenges in research ethics identified by participants over this period and how they have evolved. We will also present pre- and post-training data about confidence in ethical decision making. DISCUSSION/SIGNIFICANCE: This approach to RCR training is well-received, has evolved over time, and has led to dissemination. Success is attributed to allowing choice in topics relevant to trainees and practicality of the stepwise approach that is transferable to any situation.

OBJECTIVES/GOALS: Penn State CTSI supports KL2 career development awards for faculty seeking to become leaders in clinical and translational research. CTSAs can benefit from a better understanding of KL2 applicant profiles and trainee outcomes. Predictive modeling of KL2 records provides insights into institutional processes and continuous improvement goals. METHODS/STUDY POPULATION: Collecting KL2 application records at Penn State CTSI from 2017 to 2023, comprising both accepted and not accepted candidate profiles, this study used a generalized logistic mixed model with binomial distribution to understand the factors predictive of KL2 trainee acceptance, (n=47). The following factors were modeled as potentially predictive of scholars’ acceptance: Institution-specific Processes—Campus; Terminal Degree Type; College of Residency, Applicant Demographics and Portfolio—Minoritized or Protected Groups; Mean Application Score; Rurality Focus; Gender, and Outcomes—Post-Program h-index. RESULTS/ANTICIPATED RESULTS: Only Campus and Degree were significant factors predictive of trainee acceptance (r<.0001), with a particular campus and the MD degree-designation both exerting selectional pressures on acceptance rates. Applicant demographics were not significant historical factors in selection despite the most recent trainee cohort comprised of all women. Similarly, while our CTSA focuses on rural inequality and accessibility, a research proposal focused on rurality was not a significant factor for acceptance. Notably, NIH-scaled application scores and post-program h-indices were not significant for accepted and non-accepted applicants. DISCUSSION/SIGNIFICANCE: The absence of applicant-focused selectional pressure is striking—Penn State CTSI does not significantly select for gender, URM, or URP status. Administration is now empowered to intentionally engage, recruit, and retain from our other affiliated campuses and colleges.

OBJECTIVES/GOALS: Our project aims to assess the composition or characteristics of research papers that score high on alternative metrics. These alternative metrics including the number of newspaper mentions, social media mentions, and the attention score as catalogued on Altmetric, a tool used to document community attention for a given research paper. METHODS/STUDY POPULATION: Our study intends to 1) Utilize topic modeling to identify prevalent themes on Altmetric, and 2) Apply network analysis to elucidate the interconnectedness among universities, funding sources, journals, and publishers associated with high-attention papers. 3) Examine how these patterns vary when attention metrics shift, such as social media mentions, newspaper mentions, or the Altmetric score. We'll first perform this analysis on all types of papers and then limit the networks to Biomedical and Clinical Sciences, and Public and Allied Health Sciences to help inform what health topics garner attention. RESULTS/ANTICIPATED RESULTS: Our initial Altmetric topic models revealed sustained attention for COVID-19 and vaccination-related publications well beyond the pandemic (specifically, papers from January 2023). Health topics like cancer, dementia, and obesity also garnered high attention. Additionally, political papers (elections, democracy), climate change, and battery research had notable attention values. Further analysis needs to be done to explain why these topics gain attention and the type of attention they garner. We will construct networks to see the relationship between attention and entities like universities, funding sources, journals, and publishers. This will identify whether certain clusters of these entities produce papers with high attention or if attention is distributed evenly amoung them. DISCUSSION/SIGNIFICANCE: To gauge the broader impact of scholarly research alternative metrics beyond citations are needed. Altmetric is used widely by CTSA’s to measure the community interest in research. Understanding the types of research that gain traction on Altmetric can help researchers understand how to garner interest from the community.

OBJECTIVES/GOALS: Prostate cancer treatment is associated with significant genitourinary side effects. There is a critical need for treatment with decreased morbidity. We report the development of a novel treatment paradigm combining irreversible electroporation and lower dose radiation to provide prostate cancer patients with a less morbid treatment. METHODS/STUDY POPULATION: Intermediate risk prostate cancer patients will undergo focal irreversible electroporation followed by low dose, whole gland radiation therapy. The primary endpoint is freedom from clinically significant cancer on biopsy at 12-month follow up. Secondary endpoints include safety profile, oncologic efficacy, effectiveness of RT and need for secondary treatment. This trial (NCT05345444) and currently actively recruiting patients after initial feasibility trial. Sample size is calculated to detect an increase in the proportion of patients who are cancer free at 1-year, from 0.80 to 0.95. An exact binomial test with a 10% one-sided significance level will have 94.3% power to detect the difference between the null and alternative hypothesis when the sample size is 42. RESULTS/ANTICIPATED RESULTS: This is a clinical trial in progress. DISCUSSION/SIGNIFICANCE: Combined irreversible electroporation (IRE) and a lower dose radiotherapy (RTIRE) may provide prostate cancer patients a treatment with minimal side effects.

OBJECTIVES/GOALS: Specialty care for asthmatic children should prevent adverse asthma outcomes. This study of children receiving care in the Arkansas Medicaid program used a comparative effectiveness research design to test whether allergy specialty care was associated with reduced adverse asthma outcomes. METHODS/STUDY POPULATION: Using the Arkansas All Payer Claims Database we studied Medicaid-enrolled children with asthma using a propensity score greedy nearest neighbor one-to-one matching algorithm. We matched children with (treatment) and without (comparison) an allergy specialist visit in 2018. The propensity score model included 26 covariates (demographic, clinical, and social determinants of health). Multivariable adjusted logistic regression was used to estimate adverse asthma events (AAE: emergency department visit or inpatient hospitalization with a primary or secondary diagnosis of asthma in 2019). RESULTS/ANTICIPATED RESULTS: We identified 3,031 children with an allergy specialist visit in 2018, and successfully propensity-score matched 2,910 of the treatment group with a non-allergy specialist visit comparison group. The rate of AAEs in 2019 was 9.5% for individuals with an allergy specialist visit versus 10.1% among those without a specialist visit (p=0.450). The adjusted regression analysis showed 20.3% lower rates of AAEs (aOR: 0.797; 95% Confidence Interval: 0.650, 0.977; p=0.029) in 2019 for children with an allergy specialist visit in 2018 compared to those that did not. DISCUSSION/SIGNIFICANCE: Utilizing allergy specialist care was associated with better asthma outcomes in our statewide study of Arkansas Medicaid-enrolled children with asthma. Asthma quality metrics based on guideline-based recommendations for allergy specialist care should be considered in population health management programs.

OBJECTIVES/GOALS: Scaffolding aids learning by gradually removing assistance to encourage independence (Bickhard, 2013; Gross, 2015). Mightier is a commercially available biofeedback game that fosters emotion regulation (ER) skill practice through play. This study aims to evaluate the ability of Mightier to scaffold the learning of ER and reduce irritability. METHODS/STUDY POPULATION: Data were collected via online caregiver report. Inclusion criteria were age of child (<= 18 years) and study enrollment prior to the child engaging with Mightier. Children wear a heart rate (HR) monitor while playing games in the Mightier app library. As their HR increases, play becomes more difficult. Children can pause the game to use a scaffolded ER activity or regulate independently to return the game to normal difficulty levels. Caregivers were instructed to use the game ad libitum. Participants included caregivers of 195 children (Mage = 7.84 years old; range = 4-18 years old; 24.28% female; 74.57% male); the sample was predominantly White (56%). Caregivers completed the Affective Reactivity Index, a measure of their child’s irritability, before and after playing Mightier for 8-12 weeks. RESULTS/ANTICIPATED RESULTS: A first Wilcoxon Signed Rank Test revealed a significant reduction in the ratio of scaffolded cooldowns (using a guided activity to regulate) to total cooldowns on the first play day (Md =.50) versus the last play day (Md = .22), z = –6.51, p < .001. A second test revealed a statistically significant increase in the ratio of independent cooldowns (regulating on their own) to total cooldowns on the first play day (Md = .50) versus the last day of play (Md = .80), z = 6.34, p < .001. Given the significant, inverse relationships between scaffolded and independent ER on the first play day versus the last play day, further analyses will examine potential mediation and moderation effects of game engagement (play minutes, total cooldowns, scaffolded cooldowns, and independent cooldowns) on changes in irritability. DISCUSSION/SIGNIFICANCE: ER is vital for healthy development and protects against mental health challenges (LeBlanc etal., 2017). Across domains, scaffolded practice promotes learning (Vygotsky, 1978). Results reveal that scaffolded practice leads to independent ER during play. Future research should explore whether this pathway leads to independent ER outside of play.

OBJECTIVES/GOALS: Cannabis laws may impact cannabis and tobacco use, given high prevalence of co-use of these products among young adults (YAs). The objective of this study was to examine trends in YA any cannabis, blunt, cigarette, and cigar use from 2002-2018 in states that passed adult and medical use (AMU) or medical use only (MUO) cannabis laws during that time (N=16). METHODS/STUDY POPULATION: Using data from the National Survey on Drug Use and Health, we conducted a segmented regression analysis to calculate absolute percent change (APC) in past 30-day cannabis and tobacco use between time points. The National Cancer Institute’s Joinpoint software was used to also estimate points of inflection (Joinpoints) when the slope of a trend significantly (p<0.05) changes. Separate models were estimated for each state, with time as the independent variable measured in years. Up to three Joinpoints per model were allowed. The model with optimal Joinpoints was determined using a model selection criterion via a permutation test. Joinpoints and APCs were compared with key legalization dates to describe patterns within and across states with varying cannabis policies. RESULTS/ANTICIPATED RESULTS: Generally, the 16 states showed a steady decline in YA cigarette smoking over time, a slight decline in cigar smoking, and increases in cannabis and blunt use. AMU states had lower average 2018 prevalence of cigarette smoking than MUO states (18.3% vs. 21.5%) and higher cannabis use (32.3% vs. 21.3%). Cannabis use consistently increased following opening of MUO retail outlets. Generally, there appears to be a slight delay in cannabis use increases following AMU laws, and in some states temporary declines. For example, Washington experienced an initial decrease (-20.3%) following AMU passage (2012) then increase (+16.3%) after retail dispensaries opened in 2014. In AMU states, blunt use has surpassed cigar smoking, while in MUO states, the prevalence of blunt and cigar use is similar. DISCUSSION/SIGNIFICANCE: Introduction of cannabis laws are correlated with increases in YA cannabis and blunt use, with higher cannabis use in AMU states. Trends may also correlate other state political, economic, or social factors. Joinpoint regression can assess changes in a policy’s target behavior with no a priori assumptions regarding timing of policy effects.

OBJECTIVES/GOALS: Our objective is to explore the evolving role of evaluators within Learning Health Systems (LHSs) and the implications for evaluation approaches in these dynamic healthcare environments. We aim to disseminate lessons learned to help inform best practices for other CTSA hubs operating under a LHS model. METHODS/STUDY POPULATION: Our investigation builds upon our prior qualitative analysis of the LHS literature and contextualization of unique challenges, and potential remedies, of a LHS in Academic Health Centers. As evaluators, we are particularly interested in understanding how evaluation work is conducted in LHSs and exploring ways to optimize the role of evaluators and their skillset in this context. For this investigation, we examined the competencies necessary for evaluators working in LHS and the specialized evaluation approaches needed to fulfill these requirements. Our approach drew from multi-faceted data and experience. We leveraged insights from our literature review, direct experience within WFUSOM CTSI, and discussions with other evaluators. This combination of data sources provided the foundation for our analysis. RESULTS/ANTICIPATED RESULTS: We expect that as more health systems move toward the LHS model, they will have an increased need for various forms of evaluation, requiring resources well beyond what they are currently dedicating to evaluation. Expectations for evaluators will be enhanced in the following distinct, yet complementary, categories: generating new knowledge and translating research knowledge into practice. Anticipated results include identifying essential competencies for evaluators in LHS, such as data proficiency, clinical understanding, and adaptive skills. We also expect to uncover various evaluation approaches specific to LHS, including quality improvement studies, pragmatic trials, and stakeholder-engaged research. DISCUSSION/SIGNIFICANCE: Understanding the evolving role of evaluators and specialized evaluation approaches in LHS is crucial. It enhances the ability to generate localized evidence, customize interventions, and improve patient care. This knowledge empowers healthcare systems to adapt, innovate and deliver high-quality care for a higher impact on patient outcomes.

OBJECTIVES/GOALS: To develop and validate a tool to systematically identify benefits accruing to research within the Translational Science Benefits Model (TSBM) framework. We used a Delphi panel to reach consensus among a group of experts on criteria required for a clinical, community, economic, or policy benefit to be verified as coming from research. METHODS/STUDY POPULATION: A coding tool with proposed criteria to verify each of the 30 benefits was created at UCI to confirm the TSBM benefits resulting from funded research. We convened 11 experts from 8 CTSA hubs, who consisted of evaluators (faculty and staff) with experience using the TSBM. A web-based survey was used for Round 1, followed by a panel discussion of remaining unvalidated criteria, and a Round 2 survey as the final decision for inclusion of items in the tool. Response options for each criterion were “yes, required” or “no, not required”. Criteria that reached consensus (>70% agreement) were considered validated for inclusion in the final version. Panelist suggested criteria in Round 1 were also incorporated in the Round 2 survey for consideration by the experts. RESULTS/ANTICIPATED RESULTS: In the web-based survey for Round 1, all 11 experts participated and 92% of criteria reached the determined consensus level (N = 157). The remaining 8% of the criteria (N = 13) were discussed during the panel meeting. The discussion, in which 8 experts participated, was moderated by UCI and took place virtually via Zoom. All experts were sent a recording of the discussion and given the opportunity to post comments online about the remaining criteria before, during, and for a day after the discussion. Round 2 will include 50 newly proposed criteria from panelists and the 13 criteria that did not reach consensus in Round 1. Based on the results of Round 2, the criteria that reach consensus will be included in the final version of the coding tool that can be used across all TSBM benefits. DISCUSSION/SIGNIFICANCE: Using the Delphi Methodology, we will have a standardized set of criteria that may be applied to determine whether a TSBM benefit has resulted from a specific research project or program. This standardization will allow for aggregation and comparison of data across CTSA hubs and further multi-level evaluation of impact.